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IAVI 002

Phase:
I
Status:
Completed
Strategies:
DNA
Candidates:
DNA.HIVA
Countries:
Kenya
Volunteers:
18
Partners:
Kenya AIDS Vaccine Initiative-Kenyatta National Hospital (KAVI-KNH), Nairobi, Kenya.

 
Study Summary:
 
This is a double-blind, randomized, placebo-controlled Phase I study to evaluate the safety and immunogenicity of a candidate HIV-1 clade A DNA vaccine, pTHr.HIVA, with placebo delivered intramuscularly by a needle injection in healthy, HIV vaccine-naïve, HIV-uninfected adult male and female volunteers. On Day 0 and Day 21, study participants will receive a single intramuscular injection of either 500 micrograms of DNA in 1.0 ml (Group A, 12 volunteers) or 1.0 ml saline (Group B, placebo, 6 volunteers) in the deltoid muscle of the non-dominant arm. The distribution is 12 DNA and 6 placebos. Subjects will be followed for six months.